Imatinib Mesylate in Treating Patients With Metastatic Breast Cancer
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ClinicalTrials.gov Identifier: NCT00045188 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : January 23, 2013
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Tracking Information | ||||
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First Submitted Date ICMJE | September 6, 2002 | |||
First Posted Date ICMJE | January 27, 2003 | |||
Last Update Posted Date | January 23, 2013 | |||
Study Start Date ICMJE | August 2002 | |||
Actual Primary Completion Date | July 2004 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Objective tumor response (CR + PR), as determined by the RECIST criteria [ Time Frame: Up to 2 years ] | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Imatinib Mesylate in Treating Patients With Metastatic Breast Cancer | |||
Official Title ICMJE | Phase II Trial of STI571 in Metastatic Breast Cancer | |||
Brief Summary | Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have metastatic breast cancer. Imatinib mesylate may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth | |||
Detailed Description | PRIMARY OBJECTIVES: I. To determine the efficacy of STI571 in metastatic breast cancer (MBC) that demonstrates expression of CD117 (c-kit) and/ or PDGFR. SECONDARY OBJECTIVES: I. To determine the clinical activity of STI571 in MBC with expression of CD117 (ckit) and/ or PDGFR by evaluating progression-free survival (PFS). II. To determine the toxicity profile and tolerability of STI571 in patients with MBC. III. To define serum, tissue and imaging surrogate endpoints of activity of STI571 in MBC. OUTLINE: Patients receive oral imatinib mesylate twice daily. Treatment continues for at least 8 weeks in the absence of disease progression or unacceptable toxicity. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Treatment (imatinib mesylate)
Patients receive oral imatinib mesylate twice daily. Treatment continues for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
Interventions:
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
35 | |||
Original Enrollment ICMJE | Not Provided | |||
Study Completion Date ICMJE | Not Provided | |||
Actual Primary Completion Date | July 2004 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00045188 | |||
Other Study ID Numbers ICMJE | NCI-2012-02491 IDO1-691 N01CM17003 ( U.S. NIH Grant/Contract ) CDR0000256915 ( Registry Identifier: PDQ (Physician Data Query) ) |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | National Cancer Institute (NCI) | |||
Study Sponsor ICMJE | National Cancer Institute (NCI) | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | National Cancer Institute (NCI) | |||
Verification Date | January 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |